PES HOT/COLD COMPRESS

• K Number: K962038
• Device Name: PES HOT/COLD COMPRESS
• Manufacturer: PRINCETON ELECTRONIC SYSTEMS, INC.
• Date Cleared: 1996-11-13 ( 173 days)
• Product Code: IRT
• Regulation Number: 890.5740
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 890.5740 Powered heating pad.

(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.